510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JJRClass I

Electrolyte Controls (Assayed And Unassayed)

21 CFR 862.1660 / Clinical Chemistry
FDA source (opens on fda.gov)

JJR is the FDA product code for Electrolyte Controls (Assayed And Unassayed), a class I device type, regulated under 21 CFR 862.1660. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JJR
Device name
Electrolyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
0

Clearances, product code JJR

By decision year
17 clearances under product code JJR with a decision year between 1979 and 1999, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JJR by decision year
YearClearances
19791
19831
19841
19861
19883
19892
19901
19911
19931
19941
19951
19962
19991

Applicants with the most clearances

Product code JJR
Applicants holding the most 510(k) clearances under product code JJR
ApplicantClearances
Bionostics, Inc.2
Phoenix Diagnostics, Inc.2
Quantimetrix Corp.2
Aalto Scientific Ltd.1
Avl Scientific Corp.1
Baxter Healthcare Corporation1
Biomedical Research & Development Laboratories, Inc.1
Casco Standards1
Ciba Corning Diagnostics Corp.1
I-Stat Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code